Duns Number:026544675
Device Description: Self-Tapping Screw D2.4mm, 11mm
Catalog Number
1.900.303
Brand Name
CMF VISIONARE
Version/Model Number
1.900.303
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K180204,K180204
Product Code
DZL
Product Code Name
Screw, Fixation, Intraosseous
Public Device Record Key
9b1c6876-391f-4f4d-bdda-94ff0e82b1dc
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 21, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 441 |